- About
-
Projects
-
Column 1
- Advancing Regulatory Science
- Animal Health & Veterinary Medicine
- Expanded Access
- FDA Patient Listening Sessions
-
Column 2
- Food & Nutrition
- Improving Access to FDA Information
- Research
- Substance Use Disorders
-
Column 1
- News and Events
- Expanded Access eRequest
Around the world, researchers are working extremely hard to develop new treatments and interventions for COVID-19 with new clinical trials opening nearly every day. This directory provides you with information, including enrollment detail, about these trials. In some cases, researchers are able to offer expanded access (sometimes called compassionate use) to an investigational drug when a patient cannot participate in a clinical trial.
The information provided here is drawn from ClinicalTrials.gov.
Emergency INDs
To learn how to apply for expanded access, please visit our Guides designed to walk healthcare providers, patients and/or caregivers through the process of applying for expanded access. Please note that given the situation with COVID-19 and the need to move as fast as possible, many physicians are requesting expanded access for emergency use. In these cases, FDA will authorize treatment by telephone and treatment can start immediately. For more details, consult FDA guidance. Emergency IND is the common route that patients are receiving convalescent plasma.
Search Tips
To search this directory, simply type a drug name, condition, company name, location, or other term of your choice into the search bar and click SEARCH. For broadest results, type the terms without quotation marks; to narrow your search to an exact match, put your terms in quotation marks (e.g., “acute respiratory distress syndrome” or “ARDS”). You may opt to further streamline your search by using the Status of the study and Intervention Type options. Simply click one or more of those boxes to refine your search.
Displaying 210 of 530Bandim Health Project
Conditions: Poliovirus Vaccine, Oral, COVID, Mortality, Morbidity, Non-specific Effects of Vaccines
Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficialnon-specific effects, reducing morbidity and mortality from other infections than polio.Such beneficial non-specific effect have been observed for other live vaccines, includingmeasles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has beenstudied the most, the effects appear to be mediated through the innate immune system. TheCOVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated thatin Africa the older part of the population will be at risk of severe COVID-19. OPV iswidely used in Africa, but for children. Both polio and coronavirus are positive-strandRNA viruses, therefore it is likely that they may induce and be affected by common innateimmune mechanisms.In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigatorswill assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years ofage. The trial will have the power to test the hypothesis that OPV reduces the combinedrisk of morbidity admission or death (composite outcome) by at least 28% over thesubsequent 6 months.
University Hospital, Toulouse
Conditions: COVID-19
There is a pandemic in the world by COVID-19. Currently, the pharmacological curative orprophylactic treatments for this infection are not known. Recent studies have suggestedthat Hydroxy-Chloroquine could be effective in vitro and in vivo against COVID-19. Themain objective of this study is to assess in patients with autoimmune disease treatedwith long course Hydroxy-Chloroquine initiated before the pandemic COVID-19 had anindependent protective effect on the risk or the severity of infection with COVID-19.
National Cancer Institute (NCI)
Conditions: Covid-19 Infection
This phase I trial investigates breathing techniques and meditation for health careworkers during COVID-19 pandemic. Breathing techniques and medication may help managestress and improve lung health. The goal of this trial is to learn if breathingtechniques and meditation may help to reduce stress and improve lung health in healthcare workers during the COVID-19 pandemic.
Medical University of South Carolina
Conditions: COVID-19, Vitamin D Deficiency, Respiratory Viral Infection
The purpose of this study is to evaluate how useful vitamin D supplementation is inreducing the severity of COVID-19 symptoms and the body's inflammatory andinfection-fighting response to COVID-19. Individuals ≥50 years of age and older who aretested for COVID-19 and negative will be randomized (like flipping a coin) to eitherdaily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care.Those individuals ≥50 years of age or older who test positive for COVID-19 at baselinewill be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose(6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receivea multivitamin containing vitamin D.
Centre Hospitalier Universitaire, Amiens
Conditions: Postpartum Depression, COVID19, Prevalence, Social Distance
Postpartum depression (PPD) represent around 15% of birth in developed countries. Thecontext of the COVID-19 epidemy represents a possible source of additional emotionaldistress. The objective of this study is to determine the screening prevalence and riskfactors of postpartum depression, among women who deliver in fourth hospital in the Northof France in the context of the COVID epidemy.
Humanetics Corporation
Conditions: COVID-19, Long Covid, Pulmonary Fibrosis, Post-acute Respiratory Complications of COVID-19
This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate thesafety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lungfunction in patients that were hospitalized for severe COVID-19-related illness andcontinue to experience post-acute respiratory complications associated with Long-COVIDafter discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.
University Health Network, Toronto
Conditions: Healthcare Worker, COVID19
Recent studies have shown that some individuals may be asymptomatic but continue to shedthe COVID-19 virus. These individuals may represent a population that can unknowinglytransmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community orfrom possibly infected patients. It is important to gather data with respect to this tofurther understand the prevalence of asymptomatic carriage in individuals who work inresearch facilities, offices and clinical areas of hospitals and researchfacilities/institutes since this has important implications for infection control, aswell as staff and patient safety. The purpose of this study is to test whether aproportion of these individuals may be asymptomatic shedders of the COVID-19 virus.
Laval University
Conditions: Psychosocial Impacts of the COVID-19 Pandemic
The health crisis imposed by COVID-19 is forcing major worldwide social reorganizationthat will have profound consequences on our society. Currently, one-third of the world'spopulation (~3 billion individuals) is living under some kind of isolation or quarantinemeasures, causing an unprecedented and rapidly evolving psychosocial crisis.The psychosocial consequences of this health crisis will persist long after restrictionmeasures are lifted and the pandemic is over. This impact will be significant forindividuals facing unique contexts or challenges (e.g., older adults, individuals livingwith a disability, underprivileged families) and will most likely exacerbate existingsocial and gender inequalities in health and human development.There is an urgent need for information on the evolution of the psychosocial dimensionsof health and coping strategies used by our population and our health and social servicesstructures. Thus, this study is designed to accelerate the availability of high-quality,real-time evidence within health and social services structures to address, support andminimize psychosocial consequences of the COVID-19 pandemic. Through constantly evolvingresearch questions responsive to the course of the pandemic evolution, the rapid systemtransformations and adaptation of services, and knowledge users (KUs) needs, MAVIPAN aimsto address, document, monitor, and evaluate the following: 1. Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts. 2. Healthcare and social services workers and managers' adjustments and mitigation strategies. 3. The organization of service structures. 4. The social and economic response.To achieve these objectives, we use a mixed methods study design that combinesquantitative questionnaires and qualitative interviews to deepen our understanding ofelements such as the coping strategies used during the pandemic. A first measure wastaken during lock-down as well as a follow-up at 3 months. Another follow-up will be madeat 7 months. At least one per year follow-up will be made over the course of the study (5years). Additional measures may be taken depending on the evolution of the pandemic andthe sanitary measures put in place by the authorities.
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions: Post-Coronavirus Disease 19
Background:People who get COVID-19 have a wide range of symptoms. They also recover from COVID-19 indifferent ways. In this study, researchers will use survey data to describe the differentways people experience and recover from COVID-19. They will also use the data to helpcreate future studies to understand why some people do not fully recover.Objective:To learn more about the range and timing of symptoms that people have before, during, andafter COVID-19 infection.Eligibility:People ages 18 and older who can give documentation of a positive COVID-19 or antibodytest.Design:Participants will be screened with a telephone interview. It will take 15 minutes. Theywill provide their COVID-19 test results and medical records.Participants will complete a second telephone interview. It will take 30 60 minutes. Theywill also take online surveys every 3 months for 3 years.The interview and surveys will ask participants about their health before they gotCOVID-19, what happened while they had COVID-19, and what their recovery has been like.Participants will get log-in data to take the online surveys. Completing all of thesurveys the first time may take up to 3 hours. Follow-up surveys will take up to 30minutes. Participants do not have to complete the surveys in one sitting. They will beable to save their progress and finish the surveys later.Participants may be contacted to take part in other research studies.
Brigham and Women's Hospital
Conditions: COVID19, Thrombotic Microangiopathies, Acute Kidney Injury
Ultomiris (Ravulizumab), is a monoclonal antibody that specifically targets terminalcomplement products and is proposed for the treatment of COVID-19 inducedmicrovasculature injury and endothelial damage leading to thrombotic microangiopathy(TMA) causing acute kidney injury (AKI). Ravulizumab is to be used for participants witha confirmed diagnosis of COVID-19 who clinically or diagnostically present withdeteriorating renal function. Ravulizumab causes immediate and sustained inhibition ofthe terminal complement cascade. The use of ravulizumab could ameliorate COVID-19 inducedkidney injury due to TMA, shorten hospital stay, and improve the overall survival.